This invention relates to substantially lint-free cotton gauze. Specifically it relates to a durable hydrophilic substantially non-linting water-absorbent drapable composite material comprising hydrophilic polymer resin applied to cellulosic fiber materials.
Cotton gauze is manufactured from twisted cotton fiber which is cleaned, bleached and sterilized. During the cleaning and bleaching process the thread is exposed to chemical treatments and becomes associated with leftover starch, proteins, casein, and resins. These materials, plus small fibers, can fall out of cotton gauze to contaminate a wound. During surgery, they may enter and remain undetected in the body to cause granulomas or they may enter the vascular system to cause even more serious conditions.
The problem of linting has become a concern of the FDA in recent years. Measures are being considered by the FDA to set performance standards for gauze to contain the problem of linting. In its response to comments received on proposed regulations classifying 51 general and plastic surgery devices, the FDA stated: "FDA agrees that current literature indicates that there is no `safe` level of particulate exposure for gauze for internal use." 53(122) Fed. Reg. 23,867 (1988). It further stated, "FDA believes that a performance standard is necessary to control the design and construction of the [gauze], to reduce oarticulate matter contamination. and to assure adequate radiopacity." [emphasis added]53(122) Fed. Reg. 23,866 (1988). Thus, there is a recognized need for a substantially lint-free material to be used as a wound dressing material.
There is a serious problem of adhesion within a wound following any surgical operation. As one author stated, "[i]ntra-abdominal adhesions are now the most common cause of intestinal obstruction and the majority of adhesions are man-made." Ellis, "Internal Overhealing: The Problem of Intraperitoneal Adhesions", World J. of Surg., 4(3) 303-306 (1980). It has long been recognized that surgical gauze may be the source of such adhesions and granulomas. As early as 1966, it was stated, "[t]here is evidence that fragments of gauze introduced at operation may induce granulomata and deposition of fibrous tissue." Sturdy, et al., "Surgical Sponges: A Cause of Granuloma and Adhesion Formation", Ann. of Surg. 165(1) 128-134 (1967).
While cellulose gauze is hydrophilic, the cellulose fibers are not normally broken down by human enzyme systems. The chronic presence of such cellulose fibers remaining in a patient post-operation causes an immune reaction in the patient resulting in inflamation and adhesion. The problem is apparently worsened by use of woven cotton swabs, over use of nonwoven cotton swabs. See Levinson & Swolin, "Postoperative Adhesions: Etiology, Prevention, and Therapy", Clin. Obst. & Gyn., 23(4); 1213-1220 (1980).
There has been research into composite materials which may be used in place of cotton gauze. These materials are either less hydrophilic than gauze, less durable than gauze, or less drapable than gauze. The absorptive, hydrophilic nature of gauze is important since its primary function is as an absorbent material during surgery and wound healing. If the composite material is not durable, it will leave deposits of lint and such behind during the surgical procedure. Finally, the composite material must be drapable, or formable, to fit into spaces, such as an abdomen, during a surgical procedure. Thus, there is a need for a durable lint-free absorbent drapable composite material for use as a wound dressing material.